Container Holder Assembly

ABSTRACT

Container holder assembly for use in a medicament delivery device, comprising a tubular body elongated in an axial direction, said tubular body having a proximal end and an opposite distal end, and a retaining member releasably arranged to said tubular body for securing an elongated container placed inside the tubular body, wherein said retaining member comprises a resilient structure capable of exerting an axial force on said container in said tubular body for holding the container in a fixed position inside the tubular body and thereby avoiding displacement or breakage of the container and wherein a distal end of said container protrudes from a distal end of said tubular body.

TECHNICAL FIELD

The present invention relates to a cartridge assembly for medicamentdelivery devices and in particular to a cartridge assembly where safetyand handling aspects have been improved by the interaction of acartridge, a cartridge holder and a cartridge retainer.

BACKGROUND

A medicament delivery device, such as an injector, is often arrangedwith a container holder to allow operations to be carried out on thecontainer, for instance displacement within the injector housing duringskin penetration, expulsion of medicament by a plunger acting on thestopper in the container, penetration of the septum using a needle andreplacement of container. Because of tolerances, manufactured containersvary in size, which may result in the position of the container withinthe holder being somewhat affected during handling of the device. Forinstance, displacement of the container may occur as a result ofpenetrating the septum of the container with a needle or by suddenimpact forces to the housing of the device. If the container is notexactly positioned in relation to the holder, the stroke length of theplunger rod—and consequently the dosage set by the user or themanufacturer of the device—will not be exactly correlated to the actualposition of the container, resulting in the wrong dose being delivered.Also, movement of the container within the holder may lead to a higherrisk of breaking the container due to impact forces between the holderand the container.

A number of prior art solutions to container holders are known:

US 2007/0021718 A1 describes a spring for use as a supporting devicebetween a container and a housing in order to firmly position thecontainer within the housing. The spring is not attached to thecontainer holder but wedged between an insert and the container, orattached to the housing of a power pack. Therefore it is not suited tosecure the container to the container holder on its own.

EP 0 941 133 B1 discloses a cartridge assembly intended to key acartridge to a certain type of injection pen in order to preventcross-use of different cartridges and pens, which could result in thewrong drug being used or the patient receiving the wrong dose. Variousembodiments describe a cartridge assembly where the cartridge is securedin a cartridge holder that is adapted for a specific cartridge and for aspecific pen. Also, the rigid construction using cooperating threadedholder parts to secure the cartridge could lead to damage to thecartridge if too much force is used to join the parts.

WO 2010/097116 A1 describes a container holder for securely holding acontainer wherein the holder includes a support for the shoulder of thecontainer in the front end, flexible arms exert a compressive radialforce on the sides of the container and hooks at the rear end keep thecontainer inside the container once it has been inserted in thecontainer holder and pushed past the hooks. There is no resilient memberthat holds the container in the same position in relation to the holder,i.e. due to tolerances the container may be slightly axially displacedduring handling of the device.

US 2006/0030819 A1 discloses a cartridge container arranged withinwardly directed resilient tabs that apply a radial compressive forceon the cartridge to align and to hold it in proper orientation and tohinder axial and radial movement of the cartridge inside the cartridgecontainer during loading. The use of resilient tabs allows accommodationof cartridges of different sizes, but no compressive force is used tobias the cartridge axially.

EP 2 021 054 B1 describes an injection device wherein a syringe may bemoved from a retracted position to an extended position for dischargingits contents and wherein the syringe is held by a syringe carrier. Thesyringe is held in the carrier by arms arranged with lugs and dampersthat grip the rear surface of a flange of the syringe in order tominimize the risk of the syringe breaking by impact force such as causedby sudden movement, i.e. during extension or retraction of the syringe.No precaution is taken to fix the syringe in a predetermined positioninside the carrier.

Therefore, there is a need for a device that can securely keep thecontainer in one predetermined position in relation to the containerholder in order to be able to deliver a set dose in a safe and reliableway without damaging the holder. With regard to cost and complexity thedevice needs to be easy to manufacture and to implement in existingdevices. The resulting device must also be simple and intuitive for theend user to operate.

SUMMARY

According to the main aspect of the invention, it relates to a containerholder assembly for use in a medicament delivery device, comprising atubular body elongated in an axial direction, said tubular body having aproximal end and an opposite distal end, and a retaining memberreleasably arranged to said tubular body for securing an elongatedcontainer placed inside the tubular body, said retaining membercomprises a resilient structure capable of exerting an axial force onsaid container in said tubular body for holding the container in a fixedposition inside the tubular body and thereby avoiding breakage ordisplacement of the container wherein a distal end of said containerprotrudes from a distal end of said tubular body.

According to another aspect of the invention the container comprises ashoulder portion abutting a proximal inner annular ledge of the tubularbody.

According to a further aspect of the invention the retaining memberfurther comprises an annular housing arranged to accommodate a resilientstructure.

According to yet another aspect of the invention said retaining memberis capable of accommodating said tubular body such that a distal surfaceof an annular spacer abuts a circumferential flange of the tubular body.

According to yet a further aspect of the invention said retaining memberis adapted to be releasably attached to a proximal end of a deliverydevice such that the distal end of said container is resiliently pressedagainst a stopping element of said delivery device.

According to another aspect of the invention the resilient structurecomprises at least one resilient washer and an annular spacer.

According to a final aspect of the invention the container holderassembly is to be used in a medicament delivery device.

There are a number of advantages with the present invention. The use ofa resilient structure in a retaining member allows a container to befixed within a holder, regardless of size differences of differentcontainers, such as arising from tolerances, since the resilientstructure adapts its size to the size of the container. The containermay otherwise be accidentally displaced during handling and duringattachment of a delivery member. When the container is fixed within theholder the stroke length of a plunger of a delivery device may beaccurately determined so that precise doses can be delivered.

Another advantage of the structure of the retaining member is theresiliency that permits a softer tensioning of the grip on the containeras compared to the grip exerted by a rigid retainer. This helps toprevent damage to the container caused by careless tensioning of thecontainer holder/retainer. It also protects the container from otherwisedamaging impacts that may occur during handling of the device.

Yet another advantage of a retainer is that it prevents the containerfrom accidentally falling out of the container holder during handlingbefore it is attached to a delivery device. It is also relativelyprotected within the container holder as compared to outside the holder.

Also, since the assembly is delivered to the user in a semi-assembledstate it is easy for the user to insert a container and arrange thecontainer holder assembly to a delivery device to administer medicament.

These and other aspects and advantages of the present invention willbecome apparent from the following detailed description and from theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following description of embodiments of the invention, referencewill be made to the accompanying drawings of which:

FIG. 1 is a perspective view of a first embodiment of the presentinvention in an assembled position.

FIG. 2 is a perspective view of a first embodiment of the presentinvention showing a container outside the container holder assembly.

FIG. 3 is a perspective view of a first embodiment of the presentinvention showing the container holder assembly in a disassembledposition.

FIG. 4 is a cross-sectional view of a first embodiment of the presentinvention showing the inside of the container holder.

FIG. 5 is a perspective view of a second embodiment of the invention.

FIG. 6 is a cross-sectional view of a second embodiment of theinvention.

FIG. 7 is an exploded perspective view of a second embodiment of theinvention.

DETAILED DESCRIPTION

Embodiments of the present invention will now be described in detail. Asshould be noted in the present application, when the term “distalpart/end” is used, this refers to the part/end of the delivery device,or the parts/ends of the members thereof, which is/are located thefurthest away from the medicament delivery site of the patient.Correspondingly, when the term “proximal part/end” is used, this refersto the part/end of the delivery device, or the parts/ends of the membersthereof, which, is/are located closest to the medicament delivery siteof the patient.

According to a main aspect of the invention it relates to a containerholder assembly for use in a medicament delivery device, which containerholder assembly comprises a tubular body elongated in an axialdirection, said tubular body having a proximal end and an oppositedistal end A retaining member is releasably arranged to said tubularbody for securing an elongated container placed inside the tubular body.The retaining member comprises a resilient structure that is capable ofexerting an axial force on said container in said tubular body forholding the container in a fixed position inside the tubular body andthereby avoiding breakage or displacement of the container.

An exemplary embodiment of the present invention is shown in the FIGS.1-4. The embodiment shown in the figures is a container holder assemblyfor medicament delivery devices but is not restricted to it. FIG. 1 is aperspective view of exemplary components of such a container holderassembly. A tubular body 10, such as a container holder, is elongatedalong an axis X with a closed proximal end and an open distal end forreceiving a container 20. In order to secure the container 20 inside thetubular body 10, a retaining member 30 is arranged to the containerholder for gripping the container and resiliently urging it intoabutment with a stop surface inside the tubular body 20.

The exemplary embodiment disclosed in FIG. 1 shows the retaining member30 arranged at the open, distal end of the tubular body 10, gripping thedistal end of the container 20. The invention is not restricted to thisarrangement however. The container holder assembly may be may beconstructed in many different ways without departing from the concept ofthe present invention. The resilient structure of the retaining member30 will be explained below.

The tubular body 10 may also be arranged with radially protrudingelements 16 arranged to key the container holder assembly to a certaintype of delivery device in order to prevent the use of the assembly in adevice that it is not intended for.

A proximal part of the tubular body 10 may be arranged with an interface12, such as threads, for connecting a delivery member (not shown). Thedelivery member may be a needle, a nozzle, a mouth piece, or the like.

FIG. 2 shows the assembly in a semi-assembled state, wherein thecontainer 20 has not yet been loaded in the tubular body 10 and whereinthe retaining member 30 is loosely arranged to the tubular body 10,prepared for receiving the container 20. The physical dimensions of theassembly are adapted to a certain type of container but the presentinvention allows for large dimensional tolerances of the containersthanks to the resilient structure of the retaining member 30, whichholds the container in a predetermined position inside the containerholder despite variations in physical dimensions of the container.

An exemplary container 20, as show in FIG. 2, may contain medicament andis tubular and made of glass. A proximal end typically has a shoulderportion 26 connecting the tubular part with a neck portion and a cap 24.The cap comprises a septum that seals the proximal end of the container.The distal end of the container is sealed by an axially movable stopper22.

FIG. 3 depicts an embodiment of the invention. The retaining member 30,which is here shown outside the tubular body 10, comprises a resilientstructure that allows the body of the retaining member to be flexible inthe axial direction, i.e. to stretch or to compress, so that theproximal end and the distal end of the retaining member may be axiallydisplaced with regard to each other. The resilient structure 36 isachieved by forming circumferentially elongated cut-outs, or slits, inthe tubular wall of the retaining member 30. The slits are arranged inat least two parallel circumferentially aligned rows, wherein a spacebetween any two slits of one row is aligned with the centre of a slit ofan adjacent row.

At least two gripping means 34 are arranged on the distal annular endsurface of the retaining member 30. The gripping means 34 may be formedas distally protruding, inwardly curved hooks that are able to flexradially outwards as the container 20 is pushed inside the tubular body10. Each gripping means is aligned with the centre of one of the mostdistal slits.

The proximal portion of the retaining member 30 is arranged with a firstlocking means 32 capable of mutual mechanical connection with a secondlocking means 120 of the tubular body 10. The first locking means 32 maybe formed as at least two protrusions, or guide knobs, that extendradially outwardly from the outer circumferential surface of theretaining member 30, whereas the second locking means 120 may be formedas a cut-out, or guide track, that is able to guide a protrusion of thefirst locking means 32 along the track as the first and second lockingmeans are axially rotated in relation to each other, i.e. in the fashionof a bayonet connection. Each protrusion is aligned with the centre ofone of the most proximal slits.

The gripping means 34 are arranged to abut the distal annual end surfaceof the container 20 when the container has been placed in the tubularbody 10 and the first and second locking means are brought into lockingposition with each other (explained in detail below).

The resiliency of the retaining member 30 of the exemplary embodiment ofFIG. 3 results from the careful alignment of the slits, the grippingmeans 34 and the first locking means 32. For best performance, thenumber of gripping means equals the number of slits in the most distalrow of slits and the number of first locking means equals the number ofslits in the most proximal row of slits. Preferably, the number of slitsin one row equals the number of slits in each of the other rows. Mostpreferably, the number of slits in one row equals two. To achieve goodresiliency it is also preferable that the circumferential lengthoccupied by a slit is significantly larger than the circumferentiallength occupied by the space between two slits of any adjacent rows.

In a similar fashion, an end—preferably the distal end—of the tubularbody 10 may be arranged with a second resilient structure 110. As thecontainer holder assembly, with a container inside, is inserted by auser in a delivery device by attaching the tubular body to holding means(not shown) arranged at a proximal receiving end of the device (notshown). The distal annular end surface of the tubular body thereby comesinto abutment with a surface of the delivery device, forcing the secondresilient structure 110 to compress axially. The user may then attach adelivery member to the interface 12 in order to use the device

FIG. 4 shows a cross-section of the exemplary embodiment of the tubularbody 10. The second locking means 120 (FIG. 2) may be formed as acut-out, or guide track, that is able to guide a protrusion of the firstlocking means 32 along the track as the first and second locking meansare axially rotated in relation to each other. The track has a distallydirected opening 170 through which the first locking means 32 of theretaining member 30 may be inserted into the track. After insertion thefirst locking means is in the initial position 140 of the second lockingmeans. By slightly rotating the tubular body 10 and the retaining member30 with respect to each other, for instance by using a specialized tool,the first locking means is forced past a first stopper 130 a arranged toprevent unintentional rotation of the locking means. The first lockingmeans is then in a loading position 150, as depicted in FIG. 2. In theloading position 150 the container holder assembly is ready forinsertion of a container 20 into the tubular body 10. As the containeris pushed into the tubular body the gripping means 34 flex radiallyoutwards, snapping back as the distal end of the container passes thegripping means. The container is now loosely secured in the tubularbody, resting with its shoulder portion 26 against the inner annularledge 190 of the tubular body 10. The container will not fall out sincethe gripping means 34 is blocking movement in the distal direction andthe first locking means 32 is confined between the first stopper 130 aand a second stopper 130 b. However, in the loading position, theretaining member still does not exert an axial force on the container.

To achieve the object of the invention, i.e. to fix the container in anexact predetermined position in the tubular body 10, an axial forceneeds to be exerted between the tubular body and the container, suchthat they are pressed towards each other. In the exemplary embodiment ofFIG. 4 this is attained by further rotation of the retaining member withregard to the tubular body. When the first locking means 32 is forcedpast the second stopper 130 b the track of the second locking meansdeviates from a circumferential path to a circumferential/axial path,forcing the proximal part, i.e. the first locking means and consequentlythe whole the retaining member in a proximal, axial direction. Since thegripping means 34 is arranged to abut the distal annular surface of thecontainer 20 and the container is hindered from proximal displacementbecause it is resting with its shoulder portion 26 in abutment with theinner annular ledge 190 of the tubular body 10, the resilient structure36 begins to stretch axially in the proximal direction. The tensionedresilient structure exerts an axial force such that the gripping means34 urges the shoulder portion 26 of the container 20 and the innerannular ledge 190 of the tubular body 10 against each other.

As the retaining member and the tubular body are further rotated withregard to each other, the track of the second locking means 120eventually returns to a circumferentially aligned path. The firstlocking means is forced past the third stopper 130 c and comes to restin a holding position 160, abutting the distal surface of the track dueto the axial force exerted by the resilient structure 36.

The overall pitch of the track of the second locking means is carefullydetermined during manufacture of the assembly to achieve a force that isstrong enough to fix the container inside the tubular body, regardlessof the tolerances of the container used, but at the same time to achievea force that is not so strong as to risk damaging the container.

Another parameter that may be used to calibrate the force duringmanufacturing is the resiliency of the resilient structure 36. This maybe varied, for instance by selecting an appropriate number of rows ofslits of the resilient structure, or by the material chosen for thecontainer holder assembly, or by the thickness of the wall of theretaining member or the distance between the rows of slits, etc.

Other designs of the locking means 32, 120 are also conceivable, such asmutually engaging threads.

A second exemplary embodiment of the present invention is shown in FIGS.5-7. FIG. 5 is a perspective view of a medicament delivery device 40 towhich a container holder 10′, comprising a container (not shown), hasbeen attached using retaining member 50.

FIG. 6 shows a cross-section of the connection between the device 40 andthe container holder 10′ of FIG. 5. The retaining member 50 is, in theexemplary embodiment shown, comprised of a first part 50 a, a secondpart 50 b and a third part 50 c that together form an axially alignedannular housing with a through-going axially aligned hole foraccommodating the container holder 10′ with the container 20. Theretaining member 50 also houses a resilient structure 500 comprising atleast one resilient washer 56, and a spacer 56. If multiple resilientwashers are used, at least one supporting washer 54 is positionedbetween them in order to separate the resilient washers from each other.

The third part 50 c of the retaining member comprises attachment means(not shown) on a distal circumferential surface for mutually connectingwith engagement means 44 on a proximal circumferential surface of thedelivery device 40. Various solutions are conceivable for the mutualconnection of the retaining member and the delivery device, e.g. such asa threaded connection or bayonet connection.

The retaining member 50 and its constituent components are assembledduring manufacturing and are designed for a predetermined kind ofcontainer holder 10′, which in turn is designed to hold a predeterminedkind of container 20. The object of the invention, however, is to allowlarge tolerances in the physical dimensions of the container 20 withoutaffecting the accuracy of the dose delivery, i.e. by holding thecontainer in a fixed position in relation to the container holder, andwithout damaging the container. This is achieved by resilient fixationof the container in the holder.

The function of the retaining member 50 will now be described inconjunction with FIG. 7, which is an exploded view of the deliverydevice 40 and the container holder assembly, i.e. the retaining member50 and the container holder 10′. Also shown is an inserted explodedimage of the resilient structure 500 housed in the resilient means 50.

The resiliency of the retaining member 50 is a function of the stack ofresilient washers 56. The washers may, for instance, have a wavy shapethat results in an axial restoring force if the washers are compressed.Since the shape of the individual resilient washers is identical asupporting washer 54 may be used to separate them from each other.Otherwise, adjacently packed resilient washers would result in muchreduced flexibility.

When the delivery device is to be used a container is inserted in thetubular body 10′ by the distal end. At least two radially inwardlyprotruding cut-outs in the form of flexible tongues 195 are arranged inthe circumferential wall of the tubular body 10′ to flex radiallyoutwards as the cap 24 is pushed against the tongues in order to let thecontainer pass. Thereafter, the tongues flex back inwards, preventingreturn-movement of the container and securing it by its neck portion 28(FIG. 6) inside the tubular body 10′ such that it cannot accidentallyfall out before the container holder assembly has been attached to thedelivery device 40. When the container is secured in the tubular body,the distal end of the container still protrudes distally of the tubularbody, the function of which will be explained below.

The tubular body 10′ holding the container is then inserted in theretaining member 50 from the distal side such that the proximal surfaceof the circumferential flange 14′ arranged at the distal end of thetubular body comes to rest against the distal surface of the annularspacer 52. The container holder assembly, including the container, issubsequently attached to the proximal end of the delivery device by themutual connection described above.

As the mutual connection of the container holder assembly and thedelivery device is tightened, such as by turning the retaining member 50in relation to the delivery device 40 for mutually engaging threads orfor operating a bayonet connection, the protruding distal annularsurface of the container abuts the stopping element 42. The abuttingfunction of the stopping element could also be achieved by an integratedsurface of the delivery member 40 itself, such as a surface of thehousing.

Further tightening of the connection results in compression of theresilient washers 56 between the first part 50 a and the spacer 52resting against the flange 14′. This leads to a restoring axial force,arising from the compressed resilient washers 56, that acts on theflange 14′ to urge the tubular body 10′ in the distal direction. Sincethe container 20 abuts the stopping element 42, the inner annular ledge190′ is brought into abutment with the shoulder portion 26 of thecontainer, forcing the container against the stopping element 42. Theforce arising from the compression of the resilient washers 56 therebyfixes the container with regard to the tubular body 10′ and the deliverydevice 40.

The present invention is not limited to the above-described preferredembodiments. Various alternatives, modifications and equivalents may beused. Therefore, the above embodiment should not be taken as limitingthe scope of the invention, which is defined by the appended claims.

1-7. (canceled)
 8. A container holder that releasably attaches to aninjector, comprising: a tubular body elongated in an axial direction,the tubular body comprising a proximal end and an opposite distal end;and an integral resilient portion located at the distal end of thetubular body.
 9. The container holder of claim 8, wherein the integralresilient portion comprises a locking mechanism that mechanicallyconnects with a flexible retaining member.
 10. The container holder ofclaim 9, wherein the locking mechanism of the tubular body comprises acut-out.
 11. The container holder of claim 10, wherein the lockingmechanism of the tubular body is able to guide at least one protrusionof the flexible retaining member along the cut out, as the lockingmechanism and the flexible retaining member are axially rotated inrelation to one another.
 12. The container holder of claim 10, whereinthe cut out comprises a circumferential path.
 13. The container holderof claim 10, wherein the cut out comprises an axial path.
 14. Thecontainer holder of claim 9, wherein the locking mechanism of thetubular body comprises a guide track.
 15. The container holder of claim14, wherein the locking mechanism of the tubular body is able to guideat least one protrusion of the flexible retaining member along the guidetrack as the locking mechanism and the flexible retaining member areaxially rotated in relation to one another.
 16. The container holder ofclaim 14, wherein the guide track comprises a circumferential path. 17.The container holder of claim 14, wherein the guide track comprises anaxial path.
 18. The container holder of claim 15, wherein the lockingmechanism further comprises a distally directed opening through whichthe retaining member may be inserted into the guide track.
 19. Thecontainer holder of claim 18, wherein after insertion of the retainingmember into the distally directed opening of the locking mechanism,rotation of the tubular body with respect to the retaining member forcesthe retaining member past a stopper arranged to prevent unintentionalrotation of the locking mechanism.
 20. The container holder of claim 9,wherein the locking mechanism of the tubular body comprises a resilientstructure.
 21. The container holder of claim 8, wherein the tubular bodycomprises an elongated tubular body, the elongated tubular bodycomprising a closed proximal end and an open distal end for receiving acontainer.
 22. The container holder of claim 21, wherein the containercomprises a shoulder portion abutting a proximal inner annular ledge ofthe tubular body.
 23. The container holder of claim 9, wherein thelocking mechanism of the tubular body is configured for releasableattachment to a proximal end of the delivery device.
 24. The containerholder of claim 23, wherein, when the tubular body is releasablyattached to the delivery device, a distal annular end surface of thetubular body comes into abutment with a surface of the delivery device,forcing the locking mechanism to compress.
 25. The cartridge holder ofclaim 8, wherein the tubular body comprises a plurality of radiallyinwardly protruding cut outs arranged on a circumferential wall of thetubular body.
 26. The cartridge holder of claim 25, wherein theplurality of radially inwardly protruding cut outs comprise flexibletongues.
 27. The delivery device of claim 8, wherein the tubular bodyfurther comprises at least one radially protruding element arranged tokey the container holder to only a certain type of delivery device inorder to prevent the use of the container holder with a delivery devicethat the container holder is not intended for.
 28. The delivery deviceof claim 8, wherein the tubular body further comprises an interface forconnecting a delivery member to the tubular body.
 29. The deliverydevice of claim 28, wherein the interface comprises threads forconnecting the delivery member to the tubular body.
 30. The cartridgeholder of claim 8, wherein the container holder comprises a proximal endcomprising a shoulder portion connecting the tubular part with a neckportion and a cap, the cap comprising a septum that seals the proximalend of the container.
 31. A cartridge holder of claim 30, wherein thecontainer further comprises a stopper that seals a distal end of thecontainer.
 32. The delivery device of claim 28, wherein the interfacecomprises a bayonet connection for connecting the delivery member to thetubular body.